NDC Code | 80425-0101-2 |
Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (80425-0101-2) |
Product NDC | 80425-0101 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Tramadol Hcl |
Proprietary Name Suffix | Er |
Non-Proprietary Name | Tramadol Hcl |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20120627 |
Marketing Category Name | ANDA |
Application Number | ANDA200491 |
Manufacturer | Advanced Rx Pharmacy of Tennessee, LLC |
Substance Name | TRAMADOL HYDROCHLORIDE |
Strength | 200 |
Strength Unit | mg/1 |
Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
DEA Schedule | CIV |